The treatment of vascular diseases has grown exponentially in terms of sophistication and diversity. One area of interest relates to the ability to access the inside of the heart in order to touch, cut, move, paint, or burn areas of the heart in order to change its function, shape, conduction pattern, or to ablate a normal or an abnormal rhythm pattern.
Another area of interest pertains to the treatment of deficiencies in the heart and its chambers, valves, and vessels emanating therefrom. In certain cases of aortic stenosis or left ventricular outflow tract obstruction, surgeons have provided relief to patients by implanting a prosthetic valved conduit: extending from the apex of the left ventricle to the aorta. This conduit provides an outflow tract for flow exiting the left ventricle. The surgery leaves the natural outflow tract intact and untouched. This surgical technique has proven useful in cases of congenital or acquired supravalvular, valvular, and subvalvular stenoses where more conventional approaches (such as aortic valvotomy or commissurotomy) produce inferior results due to the severity of the obstruction. These substandard results may also be attributable to difficulties in affecting an accurate obstruction relief, or due to dropping debris from the attended valve (or other similar component). The debris can readily create an embolus that is free to travel with the blood flow and, potentially, cause a stroke (in the case of lodging in the brain) or other bodily injuries.
In more recent years, prosthetic conduits with valves have enjoyed substantial notoriety. Their popularity is due to their tremendous success rate, their efficacy, and their ability to offer extraordinary benefits to a patient.
Note that such cardiac procedures pose certain problems for a surgeon. For example, a surgeon is generally confined or restricted in his movements during the surgery, which may be due, in part, to instrumental limitations. A surgeon must often complete a number of sophisticated tasks during a given procedure. Some of these tasks should be completed somewhat concurrently or even simultaneously. Therefore, optimizing or simplifying any of these steps may yield a significant reduction in burden for a surgeon. Additionally, with the elimination of perfunctory tasks and tedious chores, the surgeon is then free to shift his attention where it is most needed: on the procedure itself.
Moreover, many surgical instruments that address issues at the apex of the heart are cumbersome, difficult to manipulate, potentially harmful to patients, and clumsy or awkward in many situations. Their deficiencies create a significant challenge for the surgeon, who is already being taxed by a number of arduous tasks. In addition, many current devices are unacceptable because they cause trauma and inflammation issues for the patient or because they have a propensity to cause strokes.
Accordingly, the ability to provide an effective medical instrument that properly accounts for the aforementioned problems presents a significant challenge for component manufactures, system designers, and surgeons alike.